510(k) K103347 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
| Applicant | Intervascular Sas, La Ciotat, FR |
| Decision | Substantially Equivalent, Feb 2, 2011 |
| Received | Nov 15, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103347
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2026 | INTERVASCULAR, SAS Cardioroot Woven Collagen Coated Vascular Graft;
Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034; Open, Classified |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.